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The Sunrise SpO2 and Pulse Rate Accuracy Validation Study (S2-SOPRAV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05386836
Recruitment Status : Completed
First Posted : May 23, 2022
Last Update Posted : June 28, 2022
Sponsor:
Information provided by (Responsible Party):
Sunrise

Brief Summary:

The purpose of this study is to evaluate the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO2 values determined from arterial blood sample specimen analyzed by a CO-oximeter. Testing is conducted under normal office environment conditions. It is expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system will meet the required specification of ARMS of 3.5% or less allowed for reflectance technology in non-motion conditions for the range of 70-100% SaO2.

A secondary goal is to evaluate the pulse rate performance simultaneously collected over the SpO2 range covered.


Condition or disease Intervention/treatment Phase
Validation Study Device: Pulse oximeter validation population Not Applicable

Detailed Description:
Subjects will be given medical grade mixtures of oxygen and nitrogen to induce stable plateaus across the range of 100% to 70% SaO2. When the reference system's blood saturation stabilizes at an acceptable plateau level, blood sampling can start. Four to eight arterial blood samples will be collected for each plateau, while keeping at least 20 seconds in between each sample and at least 30 seconds once the plateau has been reached. The blood will be immediately analyzed by the reference CO-Oximeter to measure the arterial oxygen saturation (Functional SaO2). SpO2 values from the Sunrise sensor 2 will be collected electronically simultaneously to blood drawn from the indwelling catheter. Data will be collected under non-motion conditions. The pulse rate will be simultaneously collected over the SpO2 range covered. The reference method for the computation of pulse rate accuracy will be an ECG heart rate. The total duration of the test will be about 1 hour per subject. Data analysis results will provide documentation showing SpO2 and pulse rate accuracy performance of the Sunrise sensor 2 as compared to arterial blood samples measured by Reference CO-Oximetry and to ECG heart rate, respectively.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Single-center Study Assessing the SpO2 and Pulse Rate Accuracy of the Sunrise Sensor 2 Compared to Arterial Blood Samples Oxygen Saturation Assessed by CO-oximetry and ECG Respectively, Under Non-motion Conditions in Healthy Adults
Actual Study Start Date : May 24, 2022
Actual Primary Completion Date : June 21, 2022
Actual Study Completion Date : June 21, 2022

Arm Intervention/treatment
Experimental: Healthy adult volunteers
All subjects within this single arm of the study will undergo the validation experiment as described in the description
Device: Pulse oximeter validation population
Evaluation of the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO2 values determined from arterial blood sample specimen analyzed by a CO-oximeter.




Primary Outcome Measures :
  1. SpO2 ARMS determination [ Time Frame: Within 1 month after subject recruitment ]
    SpO2 accuracy root-mean-square (ARMS) determination for the range of 70- 100%., i.e., the RMS difference between measured values and reference values.


Secondary Outcome Measures :
  1. Pulse rate ARMS determination [ Time Frame: Within 1 month after subject recruitment ]
    Pulse rate accuracy root-mean-square (ARMS) determination



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects with positive Allen's test
  • Subject must be willing and able to comply with study procedures and duration
  • Subject is a non-smoker or who has not smoked within 2 days prior to the study
  • 15% of the study population or 2 subjects (whichever is larger) with dark pigmented skin should be included in the study

Exclusion Criteria:

  • Subject is considered as being morbidly obese (defined as BMI >39.5)
  • Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
  • Subjects with known heart or cardiovascular conditions
  • Subjects with other known health condition (diabetes, thyroid disease, kidney disease/chronic renal impairment, history of seizures (except childhood febrile seizures) or epilepsy, or unexplained syncope, recent history of frequent migraine headaches, recent head injury, cancer/chemotherapy)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05386836


Locations
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Belgium
Respisom
Namur, Belgium
Sponsors and Collaborators
Sunrise
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Responsible Party: Sunrise
ClinicalTrials.gov Identifier: NCT05386836    
Other Study ID Numbers: PRO-367
First Posted: May 23, 2022    Key Record Dates
Last Update Posted: June 28, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No